Encysive completes phase 3 trials for Thelin in pulmonary arterial hypertension; regulatory reviews pending

By E. Janene Geiss

Philadelphia, Dec. 13 - Encysive Pharmaceuticals Inc. said it completed its pivotal phase 3 clinical trials for its lead drug candidate Thelin (sitaxsentan sodium) for the treatment of pulmonary arterial hypertension and it is under review by the U.S. Food and Drug Administration and the European Medicines Agency, according to an 8-K filing with the Securities and Exchange Commission.

The filing also said a recent regulatory submission for Thelin was accepted for review by the Therapeutic Goods Administration of Australia.

The company's Common Technical Document, filed with the Australian regulatory body, seeks approval to market Thelin 100 mg as a once daily oral treatment for patients with pulmonary arterial hypertension. Officials said in the filing that the administration also has granted Encysive priority evaluation for Thelin.

The company said it also plans to develop Thelin more broadly in pulmonary arterial hypertension and to explore uses beyond that indication.

But, for one indication it was exploring, Interstitial Lung Disease, the company said there were no validated endpoints to use over a short period of time with a small number of subjects, so it would not initiate a phase 2b/3 clinical study to evaluate Thelin for that disease.

The company said it will continue to evaluate other exploratory studies in this disease area. A planned proof-of-concept study with Thelin in an unnamed chronic indication has cleared FDA review and is expected to enroll its first patient late this year or early in 2006, the filing said.

In addition to Thelin, the company said it is also developing a next generation endothelin receptor antagonist, TBC3711.

TBC3711 is a more potent and selective ET(A) receptor antagonist with an improved metabolic profile, pre-clinically, the filing said.

The company said it has elected to conduct a dose-ranging study in resistant hypertension with TBC3711, rather than in pulmonary arterial hypertension as previously indicated. This study has cleared FDA review and is expected to enroll its first patient late this year or early in 2006, officials said.

Encysive is a Houston-based pharmaceutical company that develops and commercializes small molecule drugs aimed at cardiovascular and inflammatory diseases.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.